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| Name | Class |
|---|---|
| Arizona State University | OTHER |
| Blue Cross Blue Shield | OTHER |
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This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. The investigators predict that adolescents in the mindfulness intervention group will demonstrate increases in self-reported mindfulness and reductions in self- and parent-reported anxiety and depression relative to a delayed treatment control group. The investigators will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.
Interested individuals and their parent/caregiver who meet preliminary eligibility criteria during the phone screen will be scheduled for a 1-2 hour virtual study visit to complete an intake interview for study and a brief IQ test. If individuals have completed this assessment at SARRC within the last five years, they will not be re-assessed; however, they will complete a 30-minute virtual intake visit to complete the intake interview, learn about the intervention and determine if they would like to participate.
Participants in the treatment group will complete three virtual study visits (Baseline, intervention exit, 2-month follow-up), whereas participants in the delayed treatment control group will complete four virtual study visits (Baseline, wait for the period exit, intervention exit, 2 month-follow-up). After completing their second-time point (i.e., wait period exit) participants in the delayed treatment control group will be enrolled in the 8-week intervention.
The investigators anticipate that the duration of an individual participant's participation in the study from baseline data collection to study completion will be approximately 6 months. Participants may be enrolled up to 8 months prior to their baseline data collection depending on when they are recruited into the study and whether they participate in cohort 1 or cohort 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based Intervention | Experimental | The intervention will include weekly 90-minute group meetings held online through Zoom. Adolescents and parents will meet in separate groups and will learn about mindfulness-based strategies that can be used to manage and reduce stress, anxiety, and depression. They will also learn evidence-based strategies to complete daily guided mindfulness meditations using Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention. |
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| Delayed Treatment Control | No Intervention | Participants will be instructed to engage in treatment as usual during their 8-week wait period. After their wait period, participants will be enrolled in the mindfulness-based intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINDful TIME | Behavioral | The intervention will include weekly 90-minute group meetings held online through Zoom. Adolescents and parents will meet in separate groups and will learn about mindfulness-based strategies that can be used to manage and reduce stress, anxiety, and depression. They will also learn evidence-based strategies to complete daily guided mindfulness meditations using Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Children's Depression Inventory (CDI) Scores | Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores | Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores | Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness. | Post-intervention (8 weeks); 2-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Beck Youth Inventories (BYI) Scores | Adolescent-report measure of depression. Scores range from 0 to 90, with higher scores indicating higher levels of depression. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blair Braden, Ph.D | Arizona State University | Principal Investigator |
| Nicole Matthews, Ph.D | Southwest Autism Research and Resource Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40160168 | Derived | Matthews NL, Mitchell MM, Honda H, Malligo A, Boyd S, Pagni BA, Blair Braden B. Pilot randomized controlled trial of MINDful TIME, a novel telehealth mindfulness-based intervention for autistic adolescents and their caregivers. Autism. 2025 Jul;29(7):1864-1882. doi: 10.1177/13623613251328484. Epub 2025 Mar 31. |
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All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
Data will be available upon request starting 6 months after publication and will remain available for 2 years.
Data requests should be submitted to Dr. Nicole Matthews at nmatthews@autismcenter.org and must include study aims and purpose and a detailed analysis plan describing how the data will be used. Requests will be reviewed by Dr. Matthews and access to the data will be made available through a secure link to download the requested data.
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
Adolescent-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores | Parent-report measure of adolescent adaptive skills across the lifespan. Scores range from 40 to 120, with higher scores indicating better adaptive skills. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores | Parent-report measure of adolescent presence and severity of social impairment within autism spectrum. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores | Parent-report measure of adolescent executive function and self-regulation. Scores range from 30 to 90, with higher scores indicating higher levels of executive dysfunction. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores | Adolescent-report measure of mindfulness on observation, description, aware actions, non-judgmental inner experience, and non-reactivity. Factor scores range from 1 to 5, with higher scores indicating higher levels of mindfulness. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Family Quality of Life Scale (FQOL) Scores | Parent-report measure of family quality of life in family interaction, parenting, emotional well-being, physical/material well-being, and disability-related support. Scores range from 1 to 5, with higher scores indicating higher satisfaction with family quality of life. | Post-intervention (8 weeks); 2-month follow-up |
| Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores | Parent-report measure of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. Percentile scores range from 0 to 99, with higher scores indicating higher levels of parenting stress. | Post-intervention (8 weeks); 2-month follow-up |